UNICHEM- ethyl alcohol 70% safe on skin spray

UNICHEM by

Drug Labeling and Warnings

UNICHEM by is a Otc medication manufactured, distributed, or labeled by Universal Chemical Products, Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ehtyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Helps prevent the risk of infection in minor cuts, scrapes and burns.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean affected area
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glutaraldehyde, purified water USP, Isopropyl Alcohol, Glycerine

Package Label - Principal Display Panel

946.4 mL NDC: 82150-870-32

INGREDIENTS AND APPEARANCE

UNICHEM 
ethyl alcohol 70% safe on skin spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82150-870
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.25 mL  in 100 mL
GLUTARALDEHYDE (UNII: T3C89M417N)	0.03 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	26.75 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	0.75 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82150-870-32	946.4 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/24/2020

Labeler - Universal Chemical Products, Corp. (963557095)

Registrant - Universal Chemical Products, Corp. (963557095)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Chemical Products, Corp.		963557095	manufacture(82150-870)